Protege RX Tapered SECX-8-6-30-135

GUDID 00821684038697

Carotid Stent System

Covidien LP

Bare-metal carotid artery stent
Primary Device ID00821684038697
NIH Device Record Keyc7c973cd-af8f-42b7-b19a-27e6c8afc1c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtege RX Tapered
Version Model NumberSECX-8-6-30-135
Catalog NumberSECX-8-6-30-135
Company DUNS968903703
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Outer Diameter2 Millimeter
Outer Diameter6 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0
Length30 Millimeter
Catheter Gauge6 French
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100821684038697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIMSTENT, CAROTID

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-22

On-Brand Devices [Protege RX Tapered]

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00821684038703Carotid Stent System
00821684038697Carotid Stent System

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